“Are generic drugs just as safe and effective?” This question is raised by most parents since out of pocket costs are almost always higher for brand-name medications. In addition, most doctors are required by insurance carriers to substitute a generic product for a brand-name product. Most parents prefer a generic medication due to the added cost of a brand-name drug. Generally, this substitution is both safe and reasonable. There are a few situations, however, when generic substitutions can cause adverse health effects. A few medications have a narrow therapeutic index (NTI) and substitution of a generic drug for a brand-name drug can cause a change in the blood level of the drug which can cause a worsening of a medical condition or new medical problems. This can be seen in medication used to treat depression, anxiety, seizures and for medications used for blood thinning or contraception. Specific drugs in this category include levothyroxine, warfarin, phenytoin and digoxin.
Approved generic drugs have demonstrated therapeutic equivalence. The Food and Drug Administration’s (FDA) Orange Book provides the latest information on generic approvals. A drug is considered bioequivalent if testing shows the drug has bioavailability properties that fall within the 80% to 125% range of the brand-name medication.
This substitution can also occur without the doctor being notified. Many health insurance plans request and allow pharmacists to substitute generic medication. Issues raised by this substitution relate to quality standards and safety controls for drug manufacture. Simple issues including a change in pill shape or color also add to the confusion and increase the potential for errors in pill administration.
Here are some helpful tips:
· Ask the doctor or prescriber if it is safe to use a generic medication.
· Ask if there is a difference between the brand-name medication and the generic medication.
· Ask if your doctor would be able to monitor the generic medications effectiveness and increase the dose if more of the generic medication is needed due to a lower bioavailability.
· Ask the pharmacist if a generic medication was substituted for a brand-name medication.
· If you are being treated for one of the above described conditions be cautious.
Overall, the use of generic medications is safe and effective. Always discuss medication changes or medical issues that could be related to a medication change with both your doctor and your pharmacist.
